Bupropion hydrobromide - Generic Drug Details

What are the generic sources for bupropion hydrobromide and what is the scope of freedom to operate?

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrobromide has fifty-two patent family members in eighteen countries.

There are five drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for bupropion hydrobromide

International Patents:	52
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bupropion hydrobromide
What excipients (inactive ingredients) are in bupropion hydrobromide?	bupropion hydrobromide excipients list
DailyMed Link:	bupropion hydrobromide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bupropion hydrobromide

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for bupropion hydrobromide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 4
Bausch Health Americas, Inc.	Phase 4
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all bupropion hydrobromide clinical trials

Generic filers with tentative approvals for BUPROPION HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
		522MG	TABLET, EXTENDED RELEASE; ORAL
		174MG	TABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bupropion hydrobromide

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Anatomical Therapeutic Chemical (ATC) Classes for bupropion hydrobromide

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for BUPROPION HYDROBROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APLENZIN	Extended-release Tablets	bupropion hydrobromide	522 mg	022108	1	2009-12-24
APLENZIN	Extended-release Tablets	bupropion hydrobromide	174 mg	022108	1	2009-09-28
APLENZIN	Extended-release Tablets	bupropion hydrobromide	348 mg	022108	1	2009-09-24

US Patents and Regulatory Information for bupropion hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y

International Patents for bupropion hydrobromide

Country	Patent Number	Title	Estimated Expiration
South Africa	201003036	BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS
Canada	2700733
China	101784266	Bupropion hydrobromide and therapeutic applications
Canada	2578626

Supplementary Protection Certificates for bupropion hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	C 2017 047	Romania		PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	C201730057	Spain		PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for Bupropion Hydro bromide: An Industry Overview

Last updated: July 28, 2025

Introduction

Bupropion hydrobromide, marketed under brand names such as Wellbutrin and Zyban, is a well-established antidepressant and smoking cessation aid. Its unique mechanism as a norepinephrine-dopamine reuptake inhibitor distinguishes it from other antidepressants, positioning it as a vital pharmaceutical in mental health management. This comprehensive analysis explores the pharmaceutical market dynamics and financial trajectory underpinning bupropion hydrobromide, encompassing demand drivers, competitive landscape, regulatory factors, and future growth prospects.

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Market Landscape and Demand Drivers

The global antidepressant market, projected to reach USD 18 billion by 2027 (per Allied Market Research), heavily influences bupropion's market performance. The rising prevalence of depression and anxiety disorders, exacerbated by socio-economic stressors, serves as a primary demand driver. According to the World Health Organization, over 264 million individuals worldwide suffer from depression, underscoring the therapeutic need for effective pharmacological interventions such as bupropion [1].

Moreover, the increasing adoption of bupropion as a smoking cessation agent further cements its market position. Smoking-related health risks have propelled demand for cessation therapies, with bupropion being a leading choice due to its dual role in mood stabilization and nicotine withdrawal management. The global smoking cessation market is anticipated to grow at a CAGR of 10% through 2025, enhancing bupropion’s sales potential [2].

The aging population across North America and Europe also fuels the demand for antidepressant medications. As mental health issues become more recognized and destigmatized, prescription rates are expected to climb, bolstering sales figures.

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Competitive and Regulatory Dynamics

Generic proliferation significantly shapes bupropion’s market environment. Patent expirations for Wellbutrin and Zyban have opened avenues for generic manufacturers, driving prices downward and increasing accessibility. According to IQVIA data, generics account for over 80% of antidepressant prescriptions in the United States, reflecting heightened competition [3].

Pricing pressures pose a critical challenge, particularly amidst payer negotiations and healthcare reforms seeking cost containment. While branded formulations enjoy premium pricing, generics are driving market volume at reduced margins. Nonetheless, high adherence levels and well-established efficacy sustain robust sales.

Regulatory factors influence bupropion’s trajectory. Approval by agencies such as the FDA remains stable due to its longstanding safety profile. However, off-label use and emerging research necessitate continuous pharmacovigilance. Potential regulatory hurdles include formulation modifications and floating patents, which can temporarily disrupt market stability.

Research and Development (R&D) efforts aim to improve bupropion's formulations and expand indications. Extended-release formulations, combination therapies, and novel delivery mechanisms are under investigation, aiming to enhance patient adherence and treatment efficacy, thereby creating niche markets and revenue streams.

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Financial Trajectory and Revenue Analysis

Historical performance reflects consistent demand, with global sales exceeding USD 1.2 billion annually in recent years (per Evaluate Pharma). The emergence of generic versions has tempered growth but maintained substantial revenue streams.

Market segmentation reveals dominant North American consumption, constituting approximately 50-60% of global sales, followed by Europe and Asia-Pacific. The expansion into emerging markets—particularly India and China—presents considerable upside, driven by increasing mental health awareness and rising healthcare expenditure.

Pricing and reimbursement policies are central to financial forecasts. In developed countries, insurance coverage facilitates access, sustaining sales volumes. Conversely, in emerging markets, affordability constraints limit penetration, although partners and local manufacturing initiatives are addressing this gap.

Forecasts for the next five years project a tempered CAGR of approximately 3-4% globally, primarily driven by generic market penetration and patent expirations. However, niche indications, personalized medicine approaches, and improved formulations could offset stagnation, presenting avenues for premium pricing strategies.

Key financial factors influencing future performance include:

• Patent expirations: The scheduled expiry of key patents, such as the original formulation, will catalyze generic competition but also stimulate market expansion through volume sales.
• Pipeline innovations: R&D investments in new formulations (e.g., extended-release or combination therapies) can command higher prices and foster brand loyalty.
• Regulatory modifications: Approval of new indications or formulations can open additional revenue streams.

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Market Challenges and Opportunities

Challenges include escalating generic competition, pricing pressures, and the potential for adverse side effects prompting regulatory scrutiny. Moreover, increasing concern regarding neuropsychiatric side effects may necessitate further clinical studies, prolonging R&D cycles.

Opportunities are rooted in expanding indications, such as treatment-resistant depression, chronic fatigue, or off-label uses. Additionally, digital health tools integrating pharmacotherapy with telemedicine can enhance patient adherence, indirectly supporting sales.

Emerging markets represent a significant growth avenue, with increasing healthcare infrastructure investments and heightened awareness of mental health issues. Strategic local partnerships and patent strategies can facilitate market entry and profitability.

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Conclusion

Bupropion hydrobromide's market dynamics are shaped by a confluence of high demand driven by mental health and smoking cessation needs, a competitive landscape characterized by widespread generic availability, and evolving regulatory and R&D activities. Financial trajectories indicate steady revenue trajectories with potential for growth through innovation and market expansion, tempered by generic erosion and pricing pressures.

Pharmaceutical companies seeking to optimize their investment strategies should monitor patent landscapes, invest in formulation innovations, and forge local partnerships within emerging markets to capitalize on future growth opportunities.

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Key Takeaways

• The increasing global burden of depression and smoking cessation demands sustains bupropion's steady market presence.
• Generic competition has significantly pressured pricing, yet volume-based sales sustain revenues.
• Patent expirations will induce market commoditization, necessitating innovation-focused strategies.
• Emerging markets offer substantial growth opportunities, particularly through local manufacturing and partnerships.
• R&D efforts targeting extended-release formulations and new indications can preserve premium pricing and brand loyalty.

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FAQs

1. How does patent expiration impact the financial outlook for bupropion hydrobromide?
Patent expirations lead to increased generic competition, typically reducing prices and profit margins for branded formulations. However, they also broaden market access and volume sales, stabilizing overall revenue if firms adapt through innovation and expanded indications.

2. What are the primary drivers of demand for bupropion in the coming years?
Major drivers include rising prevalence rates of depression, increased adoption for smoking cessation, aging populations needing mental health management, and expanding healthcare coverage in emerging markets.

3. How significant is the role of generic competitors in shaping the market dynamics of bupropion?
Generic competitors dominate sales volumes due to lower prices, accounting for over 80% of prescriptions in the US, and exert significant pricing and revenue pressures on branded products.

4. What opportunities exist for growth beyond traditional markets?
Growth potential exists in emerging markets through localized manufacturing, strategic partnerships, and expanding indications such as treatment-resistant depression and off-label uses, supported by increasing healthcare infrastructure.

5. What is the anticipated impact of regulatory changes on the future of bupropion?
Regulatory stability favors continued sales; however, emerging research and potential label expansions or restrictions could influence market access and positioning, requiring active regulatory engagement.

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References

[1] World Health Organization. Depression Fact Sheet. 2022.
[2] Grand View Research. Smoking Cessation Market Analysis. 2021.
[3] IQVIA. US Prescription Data for Antidepressants, 2022.